CDM Systems Manager (JP7387)
Thousand Oaks, CA. (Remote pending lifting of COVID restrictions)
PPS Clinical App & Analytical Services
1+ years (with likely extensions)
3 Key Consulting is hiring an CDM Systems Manager
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Will have management responsibility for Clinical Data Management (CDM) activities related to study initiation, including the development of paper case report forms (CRFs), electronic CRFs (eCRFs), Electronic Data Capture (EDC) and paper-based clinical study databases and edit check programming. Responsibilities include staff management, tracking and managing progress on group deliverables, planning, allocating and prioritizing CDM resources, contributing to the development and delivery of CDM-specific and leading the evaluation, development and implementation of new processes and standards.
Why is the Position Open?
Additional workload on the team.
Top Must-Have Skill Sets:
Day to Day Responsibilities:
- eCOA Experience (electronic clinical outcome assessment) (4-5 years of experience).
- Data Management or Systems Experience (4+ years of experience).
- Experience with external vendors (4+ years of experience).
- Attention to detail, and excellent documentation and communication skills.
- PMP certification.
- Accountable for quality delivery and competencies within the eCOA service area.
- Oversee study level system requirements meetings with eCOA vendors and internal stakeholders.
- Assist in the design and development of study specific technical documents.
- Support the internal team in managing project related timelines and associated activities.
- Partner with data management (DM) to define the requirements for data transfers.
- Work with external resources to manage the creation and execution of user acceptance tests.
- Identify and track study-related technical issues to resolution.
- Provide a supportive framework for continuous process and quality improvements.
BS or RN degree; experience in pharmaceutical or biotech clinical data management (CDM); experience in managing study level projects
Master's Degree and 3 years of Clinical experience
Bachelor's Degree and 5 years of Clinical experience
Associate's degree and 10 years of Clinical experience.
Employee Value Proposition:
interested in working with Clinical Trial development, working with an expanding team and trial, growth working space, grow your skill set in this field, ***clinical/technology experience*** cross collaboration is a huge part for this role (inside and outside of the organization)
Large employment gaps, limited experience.
We invite qualified candidates to send your resume to firstname.lastname@example.org
. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.